Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients

March 19, 2019 updated by: Luciana Akemi Matsutani, University of Sao Paulo General Hospital

Effects of Two Physiotherapeutic Treatments in Pain and Posture of Fibromyalgia Patients: Randomized Controlled Trial

The aim of this study is to compare the effects of two physiotherapeutic treatments of fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and segmental muscle stretching exercises associated with cognitive behavioral therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia is characterized mainly by chronic widespread pain. Segmental muscle stretching therapeutic exercises reduce the shortening of myofascial structures and recover the body flexibility. It is indicated for the treatment of chronic pain caused by osteo-myo-articular dysfunction. The pain behavior may be defined as the adoption of body postures and attitudes that a person communicates his/her pain. In this way, the global postural reeducation - a method of muscles chains stretching exercises - could be an important intervention. In addition, negative thoughts and dysfunctional beliefs are usual in situations of chronic pain, compromising the health recovery process. As part of a pain catastrophizing-related therapeutic approach, physiotherapist may help patients with chronic pain to develop positive, realistic and hope attitudes as based on the cognitive behavioral therapy model.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05360-000
        • Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine of the University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria and the presence of at least 11 of 18 tender points.

Exclusion Criteria:

  • Presence of joint deformities
  • Independent walking disability
  • Making another physiotherapeutic treatment at the same time.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GPR and CBT
Global postural reeducation associated with cognitive behavioral therapy; 01 session per week for 10 weeks
Other: Global postural reeducation
Other: Cognitive behavioral therapy
ACTIVE_COMPARATOR: SMSE and CBT
Segmental muscle stretching exercises associated with cognitive behavioral therapy; 01 session per week for 10 weeks
Other: Cognitive behavioral therapy
Other: Segmental muscle stretching exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analogic scale of pain
Time Frame: 11 weeks
11 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
McGill Pain Questionnaire
Time Frame: 11 weeks
11 weeks
Dolorimetry of the 18 tender points
Time Frame: 11 weeks
11 weeks
Survey of Pain Attitudes - brief version
Time Frame: 11 weeks
11 weeks
Body posture evaluation
Time Frame: 11 weeks
11 weeks
Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)
Time Frame: 11 weeks
11 weeks
Sit-and-Reach Test
Time Frame: 11 weeks
11 weeks
Fibromyalgia Impact Questionnaire
Time Frame: 11 weeks
11 weeks
Narrative interview about self-care
Time Frame: 11 weeks
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Luciana A Matsutani, MSc, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (ESTIMATE)

March 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 053/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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